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Medical Device Regulation provides the current FDA-CDRH thinking on the regulation of medical devices. This book offers information on how devices meet criteria for being a medica… Read more
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Section 1: How to Study and Market a Medical Device
1. Overview of Medical Device Regulation
2. Regulatory Routes to Market a Medical Device
3. Premarket Notification 510(k)
4. Device Modifications Requiring new 510(k) Submission
5. Premarket Approval (PMA)
6. Investigational Device Exemption (IDE)
7. In Vitro Diagnostics
8. Clinical Studies for Medical Device
9. Medical Device Labeling
10. FDA Advisory Committees
11. Human Factors and Medical Devices
12. Mobile Medical Applications
13. Software, Cybersecurity and Wireless Coexistence
Section 2: Postmarket Activities and FDA Collaboration
14. Postmarket Activities and Requirements
15. Compliance and Enforcement
16. Quality System Regulation (QRS)
17. Risk Management
18. Meeting and Collaboration with FDA
19. Future of Medical Device Regulation
Appendix
A: FDA Guidance Documents (Medical Devices)
B: Regulatory Affairs Certification (Devices) Practice Exam Questions
C: Quality Management System (QMS) Manual
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